CN104586797A - Agomelatine dispersible tablet and preparation method thereof - Google Patents
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Abstract
The invention discloses an agomelatine dispersible tablet and a preparation method thereof. Agomelatine is taken as an active pharmaceutical ingredient which is granulated together with eudragit for masking bitter taste, the masked granules are subjected to wet granulation together with other accessories, and the tablet is finally pressed. Since agomelatine is nearly insoluble in water and is lower than 5% in absolute bioavailability, the prepared dispersible tablet can promote the dissolution of the agomelatine and increase the bioavailability of the agomelatine. By granulating the eudragit and the agomelatine together for masking bitter taste, the bitter and tongue-numbing tastes of the agomelatine are effectively masked, and the medication compliance of patients is enhanced.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly a kind of agomelatine dispersible tablet and preparation method thereof of oral quick release category.
Background technology
Agomelatine tablet (agomelatine tablets) is developed by French Shi Weiya company, specification is 25mg, it is new that its commodity are called dimension, be mainly used in the treatment of major depression's disease, obtaining the listing approval of European Union in February, 2009, is first melatonin receptor agonist antidepressants in the world.Chemical name be [
n-[2-(7-methoxy-1-naphthyl) ethyl] acetamide], molecular formula: C
15h
17nO
2, molecular weight: 243.30, its structure is as follows:
。
Agomelatine is white or off-white color crystalline powder, and easily molten in methanol, ethanol, almost insoluble in water (dissolubility is 7.76e
-03g/L), and disintegrate is the rate-limiting step of principal agent stripping, thus restriction bioavailability.It is reported, the absolute bioavailability <5% of agomelatine tablet.
The advantage that dispersible tablet has to improve rapidly the blood drug level of medicine, improves bioavailability.But one of mouthfeel parameter that to be dispersible tablet important.Because agomelatine self has very strong hardship, numb excitement, can cause significant sensation at oral mucosa, the odor mask of normal conventional cannot carry out taste masking to it.
Patent 103169669A discloses a kind of agomelatine oral cavity disintegration tablet preparation method, by the micropill containing agomelatine is carried out coating, and covers up taste.This technology is relatively loaded down with trivial details, and micropill is pressed into oral cavity disintegration tablet and there is certain technical difficulty, is easily crushed by micropill.Be difficult to realize suitability for industrialized production.
Patent CN101836966A adopts inclusion technique to carry out taste masking, adopts the material such as Eugragit L100 or Eudragit E100 to carry out enclose.Its description embodiment have employed the preparation that drying under reduced pressure technique carries out clathrate, and wet granulation after clathrate is mixed with adjuvant, tabletting.This technique is relatively loaded down with trivial details, and in suitability for industrialized production, adopts drying under reduced pressure efficiency lower, be difficult to realize suitability for industrialized production.
Find in test to adopt the method adding correctives, be difficult to the excitement covering agomelatine, therefore adopt the method to be not suitable for preparing the good agomelatine dispersible tablet of mouthfeel.
Summary of the invention
Lower for solving agomelatine bioavailability in prior art, but there is when being prepared into fast disintegrating preparations the shortcoming of bitter numb excitement, the present invention proposes a kind of agomelatine dispersible tablet and preparation method thereof, to improve the dissolution rate of agomelatine and to improve patient's compliance.
For realizing above-mentioned goal of the invention, agomelatine dispersible tablet of the present invention is made up of the component of following weight fraction: agomelatine is 1 part of meter, especially strange 0.3-5 part, filler 2 ~ 5 parts, disintegrating agent 0.5 ~ 3 part, lubricant 0.05 ~ 2 part, correctives 0.05 ~ 2 part.
Preferably, agomelatine dispersible tablet is made up of forming of following weight fraction: agomelatine 1 part meter, especially strange 0.5-3 part, filler 3-5, disintegrating agent 0.5-2 part, lubricant 0.05-1 part, correctives 0.05-1 part.
Agomelatine dispersible tablet, is characterized in that, one or both combinations that described is very especially in E100, I100, S100; Described disintegrating agent be in carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone any one or multiple; Described filler be in microcrystalline Cellulose, mannitol, lactose, starch, dextrin any one or multiple; Described lubricant be in Pulvis Talci, stearic acid, magnesium stearate, micropowder silica gel any one or multiple; Described correctives be in the fruit essences such as aspartame, acesulfame potassium, Mentholum, Fructus Fragariae Ananssae any one or multiple.
The preparation method of agomelatine dispersible tablet, it is characterized in that, comprise the steps: the agomelatine getting 1 parts by weight, with the especially strange mix homogeneously of 0.5-3 parts by weight, rear employing alcohol-water solution is granulated as wetting agent, 24 mesh sieves are granulated, and in baking oven after drying, use as taste masked particle.Take taste masked particle, add inventory in conversion, mix homogeneously, adopt alcohol-water solution as wetting agent, 24 mesh sieves are granulated, and in baking oven after drying, obtain agomelatine dispersible tablet with additional adjuvant mixed pressuring plate.
The preparation method of described agomelatine dispersible tablet, is characterized in that, described wetting agent is dehydrated alcohol, purified water or both mixed solutions; The preparation method of described agomelatine dispersible tablet, is characterized in that, taste masked particle completes with adding being blended in three-dimensional mixer or wet mixing pelletizer of adjuvant in all the other; The preparation method of described agomelatine dispersible tablet, is characterized in that, oven drying temperature is 40-80 DEG C.
Described agomelatine dispersible tablet meets dispersing uniformity requirement.Dispersing uniformity <3min.
Compared with prior art, the present invention carries out simple granulation by especially strange and agomelatine and carries out taste masking, and adopts oven drying to prepare taste masked particle, improves the mouthfeel of medicine.Because agomelatine is almost insoluble in water, prepared composition discrete piece, is conducive to facilitating medicine absorption in vivo, improves the bioavailability of medicine.Prepared composition discrete piece, enhances patient consumes's compliance.
Detailed description of the invention
Below in conjunction with specific embodiment, the invention will be further described, but do not limit protection scope of the present invention.
Embodiment 1
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Especially strange | 12.5 g |
| Lactose (filler) | 100.0g |
| Polyvinylpolypyrrolidone (disintegrating agent) | 20.0g |
| Microcrystalline Cellulose (filler) | 20.0 g |
| Cross-linking sodium carboxymethyl cellulose (disintegrating agent) | 14.0 g |
| Acesulfame potassium (correctives) | 4.5g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
1) agomelatine and recipe quantity are especially strange, mix homogeneously, adopt purified water to granulate, after oven drying, obtain agomelatine taste masked particle;
2) adopt equivalent method of progressively increasing progressively to add diluent, disintegrating agent, lubricant, after mixing of repeatedly sieving, adopt alcohol water as wetting agent, granulate, after dry, additional tabletting obtains agomelatine dispersible tablet;
3) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%.
result of the test
Mouthfeel: slightly bitter, but can accept
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 89.23%.
Embodiment 2
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Especially strange | 20 g |
| Mannitol (filler) | 96.0g |
| Low-substituted hydroxypropyl cellulose (disintegrating agent) | 15.0g |
| Microcrystalline Cellulose (filler) | 25.0 g |
| Carboxymethyl starch sodium (disintegrating agent) | 10.0 g |
| Acesulfame potassium (correctives) | 4.5g |
| Mentholum (correctives) | 0.5g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
1) agomelatine and recipe quantity are especially strange, mix homogeneously, adopt purified water to granulate, after oven drying, obtain agomelatine taste masked particle;
2) adopt equivalent method of progressively increasing progressively to add diluent, disintegrating agent, lubricant, after mixing of repeatedly sieving, adopt alcohol water as wetting agent, granulate, after dry, additional tabletting obtains agomelatine dispersible tablet;
3) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%.
result of the test
Mouthfeel: without bitter picotement, taste is slightly sweet, has a little refrigerant sense.
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 88.54%.
Embodiment 3
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Especially strange | 25 g |
| Mannitol (filler) | 96.0g |
| Low-substituted hydroxypropyl cellulose (disintegrating agent) | 15.0g |
| Starch (filler) | 25.0 g |
| Carboxymethyl starch sodium (disintegrating agent) | 5.0 g |
| Acesulfame potassium (correctives) | 4g |
| Mentholum (correctives) | 1g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
1) agomelatine and recipe quantity are especially strange, mix homogeneously, adopt purified water to granulate, after oven drying, obtain agomelatine taste masked particle;
2) adopt equivalent method of progressively increasing progressively to add diluent, disintegrating agent, lubricant, after mixing of repeatedly sieving, adopt alcohol water as wetting agent, granulate, after dry, additional tabletting obtains agomelatine dispersible tablet;
3) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%.
result of the test
Mouthfeel: without bitter numb excitement, have refrigerant sense.
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 87.79%.
Embodiment 4
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Especially strange | 65 g |
| Lactose (filler) | 75.0g |
| Carboxymethylstach sodium (disintegrating agent) | 11.0g |
| Dextrin (filler) | 10.0 g |
| Carboxymethyl starch sodium (disintegrating agent) | 5.0 g |
| Acesulfame potassium (correctives) | 4g |
| Strawberry essence (correctives) | 1g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
1) agomelatine and recipe quantity are especially strange, mix homogeneously, adopt purified water to granulate, after oven drying, obtain agomelatine taste masked particle;
2) adopt equivalent method of progressively increasing progressively to add diluent, disintegrating agent, lubricant, after mixing of repeatedly sieving, adopt alcohol water as wetting agent, granulate, after dry, additional tabletting obtains agomelatine dispersible tablet;
3) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%.
result of the test
Mouthfeel: without bitter numb excitement, have strawberry flavor.
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 89.29%.
Embodiment 5
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Lactose (filler) | 135.0g |
| Carboxymethylstach sodium (disintegrating agent) | 16.0g |
| Dextrin (filler) | 10.0 g |
| Carboxymethyl starch sodium (disintegrating agent) | 5.0 g |
| Acesulfame potassium (correctives) | 4g |
| Mentholum (correctives) | 1g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
1) agomelatine and Nei Jia adjuvant mix homogeneously, adopts 30% alcohol water to granulate, oven drying.After add additional materials result and obtain agomelatine dispersible tablet;
2) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%;
result of the test
Mouthfeel: bitter numb excitement.
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 83.29%.
Embodiment 6
Agomelatine dispersible tablet is formulated by following component, by 1000 consumptions:
| Agomelatine | 25.0 g |
| Lactose (filler) | 135.0g |
| Carboxymethylstach sodium (disintegrating agent) | 16.0g |
| Dextrin (filler) | 10.0 g |
| Carboxymethyl starch sodium (disintegrating agent) | 5.0 g |
| Acesulfame potassium (correctives) | 4g |
| Mentholum (correctives) | 1g |
| Stearic acid (lubricant) | 2.0g |
| Magnesium stearate (lubricant) | 2.0 g |
Its preparation method comprises the steps:
(1) agomelatine and acesulfame potassium and Mentholum grind in mortar, after add in add material and adopt 30% alcohol water to granulate, oven drying, then adds additional materials result and obtains agomelatine dispersible tablet;
(2) by the dispersible tablet for preparing according to method in import registered standard, detect stripping curve, 45min should reach more than 80%.
result of the test
Mouthfeel: bitter numb excitement.
Compressibility: good
Friability: conform with the regulations
Outward appearance: bright and clean attractive in appearance
Dispersing uniformity: conform with the regulations
Average dissolution: 82.29%.
Can be found by above embodiment, the simple hardship fiber crops excitement adopting correctives can not cover agomelatine, adopt especially strange preferential technique of granulating to carry out taste masking and be through that great many of experiments gropes, and this technique not affect the stripping of medicine.
Above embodiments of the invention have been described in detail, but described content being only preferred embodiment of the present invention, can not being considered to for limiting practical range of the present invention.All equalizations done according to the present patent application scope change and improve, and all should still belong within patent covering scope of the present invention.
Claims (9)
1. an agomelatine dispersible tablet, is characterized in that, it is made up of the component of following weight fraction: agomelatine is 1 part of meter, especially strange 0.3-5 part, filler 2 ~ 5 parts, disintegrating agent 0.5 ~ 3 part, lubricant 0.05 ~ 2 part, correctives 0.05 ~ 2 part.
2. according to claim 1, preferably, agomelatine dispersible tablet is made up of forming of following weight fraction: agomelatine 1 part meter, especially strange 0.5-3 part, filler 3-5, disintegrating agent 0.5-2 part, lubricant 0.05-1 part, correctives 0.05-1 part.
3. agomelatine dispersible tablet according to claim 1, is characterized in that, one or both combinations that described is very especially in E100, I100, S100.
4. agomelatine dispersible tablet according to claim 1, is characterized in that:
Described disintegrating agent be in carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone any one or multiple;
Described filler be in microcrystalline Cellulose, mannitol, lactose, starch, dextrin any one or multiple;
Described lubricant be in Pulvis Talci, stearic acid, magnesium stearate, micropowder silica gel any one or multiple;
Described correctives be in the fruit essences such as aspartame, acesulfame potassium, Mentholum, Fructus Fragariae Ananssae any one or multiple.
5. the preparation method of the agomelatine dispersible tablet described in claim 1, is characterized in that, comprise the steps:
Get the agomelatine of 1 parts by weight, with the especially strange mix homogeneously of 0.5-3 parts by weight, rear employing alcohol-water solution is granulated as wetting agent, and 24 mesh sieves are granulated, and in baking oven after drying, use as taste masked particle; Take taste masked particle, add inventory in conversion, mix homogeneously, adopt alcohol-water solution as wetting agent, 24 mesh sieves are granulated, and in baking oven after drying, obtain agomelatine dispersible tablet with additional adjuvant mixed pressuring plate.
6. the preparation method of agomelatine dispersible tablet according to claim 5, is characterized in that, described wetting agent is dehydrated alcohol, purified water or both mixed solutions.
7. the preparation method of agomelatine dispersible tablet according to claim 5, is characterized in that, taste masked particle is mixed into three-dimensional mixer or wet mixing pelletizer with what add adjuvant in all the other.
8. the preparation method of agomelatine dispersible tablet according to claim 5, is characterized in that, oven drying temperature is 40-80 DEG C.
9. agomelatine dispersible tablet meets dispersing uniformity requirement according to claim 1, dispersing uniformity <3min.
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Cited By (5)
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| CN105412036A (en) * | 2015-12-24 | 2016-03-23 | 北京康立生医药技术开发有限公司 | Brexpiprazole orally disintegrating tablets |
| CN106333929A (en) * | 2016-09-24 | 2017-01-18 | 万特制药(海南)有限公司 | Agomelatine-containing dispersible tablet and preparation method thereof |
| CN106692039A (en) * | 2015-08-04 | 2017-05-24 | 恩瑞生物医药科技（上海）有限公司 | Agomelatine oral liquid preparation as well as preparation method and application thereof |
| CN109589313A (en) * | 2017-10-01 | 2019-04-09 | 万特制药(海南)有限公司 | Agomelatine dispersible tablet and preparation method thereof |
| CN109589314A (en) * | 2017-10-01 | 2019-04-09 | 万全万特制药（厦门）有限公司 | Preparation method containing hydrobromic acid Vortioxetine oral disintegrating tablet |
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Application publication date: 20150506 |